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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 27, 2004
Date Posted August 17, 2004
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-1377-04
Recall Event ID 29684
510(K)Number k981799  
Product Classification Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
Product Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Code Information Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Mark Littlefield
Manufacturer Reason
for Recall
Precipitate formed in product.
FDA Determined
Cause 2
Action Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.
Quantity in Commerce 758
Distribution Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGX and Original Applicant = ABBOTT LABORATORIES